Trial Outcomes & Findings for An Immuno-therapy Study to Evaluate the Effectiveness, Safety and Tolerability of Nivolumab or Nivolumab in Combination With Other Agents in Patients With Advanced Liver Cancer (NCT NCT01658878)
NCT ID: NCT01658878
Last Updated: 2025-12-24
Results Overview
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
657 participants
Primary outcome timeframe
From first dose of study medication through 100 days following last dose of study treatment (Assessed approximately 04 months up to a max of approximately 106 months)
Results posted on
2025-12-24
Participant Flow
A total of 657 participants were randomized and 650 received treatment across six cohorts. Randomization occurred in Cohorts 3, 4, and 6, while Cohorts 1, 2, and 5 included non-randomized participants.
Participant milestones
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pre-Treatment Period
STARTED
|
1
|
3
|
3
|
3
|
13
|
3
|
4
|
3
|
5
|
3
|
3
|
4
|
56
|
57
|
50
|
51
|
61
|
66
|
50
|
49
|
49
|
49
|
36
|
35
|
|
Pre-Treatment Period
Randomized
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
61
|
66
|
50
|
49
|
49
|
0
|
36
|
35
|
|
Pre-Treatment Period
COMPLETED
|
1
|
3
|
3
|
3
|
13
|
3
|
4
|
3
|
5
|
3
|
3
|
4
|
56
|
57
|
50
|
51
|
60
|
62
|
49
|
49
|
48
|
49
|
36
|
35
|
|
Pre-Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period
STARTED
|
1
|
3
|
3
|
3
|
13
|
3
|
4
|
3
|
5
|
3
|
3
|
4
|
56
|
57
|
50
|
51
|
60
|
62
|
49
|
49
|
48
|
49
|
36
|
35
|
|
Treatment Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period
NOT COMPLETED
|
1
|
3
|
3
|
3
|
13
|
3
|
4
|
3
|
5
|
3
|
3
|
4
|
56
|
57
|
50
|
51
|
60
|
62
|
49
|
49
|
48
|
49
|
36
|
35
|
Reasons for withdrawal
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment Period
Disease Progression
|
1
|
3
|
2
|
1
|
13
|
3
|
4
|
3
|
5
|
3
|
3
|
4
|
43
|
48
|
33
|
46
|
41
|
42
|
28
|
37
|
37
|
39
|
27
|
19
|
|
Treatment Period
Study Drug Toxicity
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
1
|
5
|
0
|
5
|
10
|
12
|
4
|
2
|
3
|
2
|
6
|
|
Treatment Period
Maximum Clinical Benefit
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period
Other Reasons
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
2
|
1
|
1
|
3
|
1
|
4
|
0
|
0
|
4
|
|
Treatment Period
Participant No Longer Meets Study Criteria
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period
Poor/Non-compliance
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period
Participant Withdrew Consent
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
0
|
2
|
1
|
2
|
1
|
0
|
2
|
2
|
|
Treatment Period
Participant Request to Discontinue Study Treatment
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
4
|
3
|
2
|
1
|
2
|
0
|
1
|
1
|
2
|
0
|
1
|
|
Treatment Period
Adverse Event Related to Study Drug
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Treatment Period
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
3
|
3
|
2
|
3
|
3
|
4
|
3
|
|
Treatment Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
1
|
0
|
Baseline Characteristics
An Immuno-therapy Study to Evaluate the Effectiveness, Safety and Tolerability of Nivolumab or Nivolumab in Combination With Other Agents in Patients With Advanced Liver Cancer
Baseline characteristics by cohort
| Measure |
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
n=56 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
n=57 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
n=50 Participants
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
n=51 Participants
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
n=61 Participants
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
n=66 Participants
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
n=50 Participants
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
n=49 Participants
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
n=49 Participants
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
n=49 Participants
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
n=36 Participants
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
n=35 Participants
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
Total
n=657 Participants
Total of all reporting groups
|
Cohort 1 Uninfected HCC: Treatment 1
n=1 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
n=13 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
n=3 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
n=4 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
n=3 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
n=5 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
n=3 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
n=3 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
n=4 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=87 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=13 Participants
|
28 Participants
n=13 Participants
|
25 Participants
n=12 Participants
|
38 Participants
n=13 Participants
|
24 Participants
n=205 Participants
|
33 Participants
n=27 Participants
|
31 Participants
n=21 Participants
|
24 Participants
n=27 Participants
|
36 Participants
n=29 Participants
|
16 Participants
n=30 Participants
|
18 Participants
n=36 Participants
|
16 Participants
n=36 Participants
|
340 Participants
n=37 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
2 Participants
n=219 Participants
|
9 Participants
n=880 Participants
|
2 Participants
n=5449 Participants
|
2 Participants
n=391 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=87 Participants
|
3 Participants
n=13 Participants
|
3 Participants
n=13 Participants
|
|
Age, Categorical
>=65 years
|
33 Participants
n=13 Participants
|
29 Participants
n=13 Participants
|
25 Participants
n=12 Participants
|
13 Participants
n=13 Participants
|
37 Participants
n=205 Participants
|
33 Participants
n=27 Participants
|
19 Participants
n=21 Participants
|
25 Participants
n=27 Participants
|
13 Participants
n=29 Participants
|
33 Participants
n=30 Participants
|
18 Participants
n=36 Participants
|
19 Participants
n=36 Participants
|
317 Participants
n=37 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=60 Participants
|
1 Participants
n=219 Participants
|
4 Participants
n=880 Participants
|
1 Participants
n=5449 Participants
|
2 Participants
n=391 Participants
|
3 Participants
n=9 Participants
|
4 Participants
n=3 Participants
|
1 Participants
n=87 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=13 Participants
|
15 Participants
n=13 Participants
|
8 Participants
n=12 Participants
|
12 Participants
n=13 Participants
|
10 Participants
n=205 Participants
|
10 Participants
n=27 Participants
|
7 Participants
n=21 Participants
|
12 Participants
n=27 Participants
|
9 Participants
n=29 Participants
|
10 Participants
n=30 Participants
|
4 Participants
n=36 Participants
|
5 Participants
n=36 Participants
|
122 Participants
n=37 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=219 Participants
|
3 Participants
n=880 Participants
|
1 Participants
n=5449 Participants
|
1 Participants
n=391 Participants
|
2 Participants
n=9 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=87 Participants
|
1 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=13 Participants
|
42 Participants
n=13 Participants
|
42 Participants
n=12 Participants
|
39 Participants
n=13 Participants
|
51 Participants
n=205 Participants
|
56 Participants
n=27 Participants
|
43 Participants
n=21 Participants
|
37 Participants
n=27 Participants
|
40 Participants
n=29 Participants
|
39 Participants
n=30 Participants
|
32 Participants
n=36 Participants
|
30 Participants
n=36 Participants
|
535 Participants
n=37 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=60 Participants
|
2 Participants
n=219 Participants
|
10 Participants
n=880 Participants
|
2 Participants
n=5449 Participants
|
3 Participants
n=391 Participants
|
1 Participants
n=9 Participants
|
4 Participants
n=3 Participants
|
3 Participants
n=87 Participants
|
2 Participants
n=13 Participants
|
4 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
White
|
38 Participants
n=13 Participants
|
34 Participants
n=13 Participants
|
29 Participants
n=12 Participants
|
4 Participants
n=13 Participants
|
39 Participants
n=205 Participants
|
42 Participants
n=27 Participants
|
12 Participants
n=21 Participants
|
20 Participants
n=27 Participants
|
15 Participants
n=29 Participants
|
27 Participants
n=30 Participants
|
26 Participants
n=36 Participants
|
23 Participants
n=36 Participants
|
337 Participants
n=37 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=60 Participants
|
3 Participants
n=219 Participants
|
11 Participants
n=880 Participants
|
3 Participants
n=5449 Participants
|
3 Participants
n=391 Participants
|
2 Participants
n=9 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=87 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
2 Participants
n=12 Participants
|
2 Participants
n=13 Participants
|
1 Participants
n=205 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=29 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
21 Participants
n=37 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
1 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=87 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
Asian
|
16 Participants
n=13 Participants
|
22 Participants
n=13 Participants
|
18 Participants
n=12 Participants
|
45 Participants
n=13 Participants
|
19 Participants
n=205 Participants
|
21 Participants
n=27 Participants
|
37 Participants
n=21 Participants
|
27 Participants
n=27 Participants
|
30 Participants
n=29 Participants
|
20 Participants
n=30 Participants
|
8 Participants
n=36 Participants
|
10 Participants
n=36 Participants
|
291 Participants
n=37 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
1 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
1 Participants
n=391 Participants
|
1 Participants
n=9 Participants
|
4 Participants
n=3 Participants
|
3 Participants
n=87 Participants
|
3 Participants
n=13 Participants
|
4 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=87 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=37 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=87 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
2 Participants
n=205 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
6 Participants
n=37 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=87 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=29 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=37 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=5449 Participants
|
0 Participants
n=391 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=87 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
PRIMARY outcome
Timeframe: From first dose of study medication through 100 days following last dose of study treatment (Assessed approximately 04 months up to a max of approximately 106 months)Population: All treated participants
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=1 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
n=13 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
n=3 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
n=4 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
n=3 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
n=5 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
n=3 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
n=3 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
n=4 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
n=56 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
n=57 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
n=50 Participants
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
n=51 Participants
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
n=60 Participants
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
n=62 Participants
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
n=49 Participants
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
n=49 Participants
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
n=48 Participants
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
n=49 Participants
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
n=36 Participants
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
n=35 Participants
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
1 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
13 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
56 Participants
|
56 Participants
|
50 Participants
|
51 Participants
|
58 Participants
|
59 Participants
|
48 Participants
|
47 Participants
|
48 Participants
|
47 Participants
|
36 Participants
|
35 Participants
|
PRIMARY outcome
Timeframe: From first dose of study medication through 100 days following last dose of study treatment (Assessed approximately 04 months up to a max of approximately 106 months)Population: All treated participants
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=1 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
n=13 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
n=3 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
n=4 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
n=3 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
n=5 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
n=3 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
n=3 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
n=4 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
n=56 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
n=57 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
n=50 Participants
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
n=51 Participants
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
n=60 Participants
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
n=62 Participants
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
n=49 Participants
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
n=49 Participants
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
n=48 Participants
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
n=49 Participants
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
n=36 Participants
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
n=35 Participants
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
34 Participants
|
28 Participants
|
29 Participants
|
21 Participants
|
27 Participants
|
25 Participants
|
30 Participants
|
27 Participants
|
29 Participants
|
31 Participants
|
17 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: From first dose of study medication through 100 days following last dose of study treatment (Assessed approximately 04 months up to a max of approximately 106 months)Population: All treated participants
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=1 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
n=13 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
n=3 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
n=4 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
n=3 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
n=5 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
n=3 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
n=3 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
n=4 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
n=56 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
n=57 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
n=50 Participants
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
n=51 Participants
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
n=60 Participants
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
n=62 Participants
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
n=49 Participants
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
n=49 Participants
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
n=48 Participants
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
n=49 Participants
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
n=36 Participants
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
n=35 Participants
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events Leading to Discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
8 Participants
|
10 Participants
|
3 Participants
|
14 Participants
|
16 Participants
|
16 Participants
|
7 Participants
|
10 Participants
|
8 Participants
|
7 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: From first dose of study medication until study closure (Up to approximately 144 months)Population: All treated participants
Number of participants who died during the study.
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=1 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
n=13 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
n=3 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
n=4 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
n=3 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
n=5 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
n=3 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
n=3 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
n=4 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
n=56 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
n=57 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
n=50 Participants
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
n=51 Participants
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
n=60 Participants
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
n=62 Participants
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
n=49 Participants
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
n=49 Participants
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
n=48 Participants
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
n=49 Participants
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
n=36 Participants
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
n=35 Participants
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Died
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
13 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
49 Participants
|
52 Participants
|
40 Participants
|
45 Participants
|
52 Participants
|
53 Participants
|
35 Participants
|
41 Participants
|
40 Participants
|
48 Participants
|
29 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: From first dose of study medication through 100 days following last dose of study treatment (Assessed approximately 04 months up to a max of approximately 106 months)Population: All treated participants
Participants with abnormalities in liver function tests related to potential drug-induced liver injury. Blood samples were collected and analyzed for liver function parameters, including alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Abnormalities were assessed relative to the upper limit of normal (ULN) for each parameter. Abbreviations: ALT = Alanine Aminotransferase; AST = Aspartate Aminotransferase; ULN = Upper Limit of Normal.
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=1 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
n=13 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
n=3 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
n=4 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
n=3 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
n=5 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
n=3 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
n=3 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
n=4 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
n=56 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
n=57 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
n=48 Participants
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
n=51 Participants
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
n=59 Participants
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
n=60 Participants
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
n=47 Participants
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
n=49 Participants
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
n=45 Participants
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
n=47 Participants
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
n=35 Participants
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
n=34 Participants
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT or AST > 15 X ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Total Bilirubin > 8 X ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT or AST > 3 X Upper limit of Normal (ULN)
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
22 Participants
|
20 Participants
|
32 Participants
|
12 Participants
|
23 Participants
|
21 Participants
|
29 Participants
|
25 Participants
|
23 Participants
|
27 Participants
|
23 Participants
|
21 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Alanine Transaminase (ALT) OR AST > 5 X ULN
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
10 Participants
|
10 Participants
|
22 Participants
|
5 Participants
|
9 Participants
|
7 Participants
|
22 Participants
|
14 Participants
|
11 Participants
|
17 Participants
|
12 Participants
|
19 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT or Aspartate Transaminase (AST) > 10 X ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
10 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
8 Participants
|
7 Participants
|
7 Participants
|
2 Participants
|
5 Participants
|
9 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
ALT or AST > 20 X ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Total Bilirubin > 2 X ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
9 Participants
|
10 Participants
|
6 Participants
|
13 Participants
|
12 Participants
|
11 Participants
|
9 Participants
|
2 Participants
|
17 Participants
|
5 Participants
|
8 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Total Bilirubin >8XULN if Elevated at Entry Or >5XULN if Normal at Entry
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Concurrent ALT OR AST Elevation > 3 X ULN with Total Bilirubin > 2 X ULN within One Day
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
7 Participants
|
5 Participants
|
9 Participants
|
10 Participants
|
9 Participants
|
7 Participants
|
1 Participants
|
10 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Concurrent ALT or AST elevation > 3 X ULN with Total Bilirubin > 2 X ULN within 30 Days
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
7 Participants
|
5 Participants
|
9 Participants
|
11 Participants
|
9 Participants
|
7 Participants
|
1 Participants
|
11 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Concurrent Alt>=10XULN & Total Bilirubin >=2XULN Or 2X Baseline if Elevated Total Bilirubin at Entry
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From first dose of study medication through 100 days following last dose of study treatment (Assessed approximately 04 months up to a max of approximately 106 months)Population: All treated participants with at least one on-treatment thyroid stimulating hormone (TSH) measurement.
Number of participants with thyroid-related laboratory abnormalities during the study. Blood samples were collected and analyzed for thyroid function markers (FT3, FT4). Abnormalities were assessed against LLN and ULN for each parameter. Abbreviations: FT3 = Free T3; FT4 = Free T4; LLN = Lower Limit of Normal; ULN = Upper Limit of Normal; TSH = Thyroid Stimulating Hormone
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=1 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
n=13 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
n=3 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
n=4 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
n=3 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
n=5 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
n=3 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
n=3 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
n=4 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
n=56 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
n=56 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
n=47 Participants
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
n=50 Participants
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
n=54 Participants
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
n=57 Participants
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
n=41 Participants
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
n=38 Participants
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
n=42 Participants
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
n=41 Participants
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
n=35 Participants
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
n=32 Participants
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN (Upper Limit of Normal)
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
20 Participants
|
23 Participants
|
21 Participants
|
17 Participants
|
15 Participants
|
19 Participants
|
23 Participants
|
15 Participants
|
15 Participants
|
6 Participants
|
21 Participants
|
17 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
10 Participants
|
7 Participants
|
8 Participants
|
9 Participants
|
2 Participants
|
6 Participants
|
16 Participants
|
13 Participants
|
10 Participants
|
5 Participants
|
6 Participants
|
9 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN with all other FT3/FT4 test values >= LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
11 Participants
|
8 Participants
|
14 Participants
|
10 Participants
|
6 Participants
|
9 Participants
|
11 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
11 Participants
|
6 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN with FT3/FT4 test missing
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN with TSH >= LLN at baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
2 Participants
|
4 Participants
|
15 Participants
|
12 Participants
|
9 Participants
|
5 Participants
|
4 Participants
|
9 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN with at least one FT3/FT4 test value > ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
9 Participants
|
6 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN with all other FT3/FT4 test values <= ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
8 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN with FT3/FT4 test missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN with TSH <= ULN at baseline
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
15 Participants
|
17 Participants
|
13 Participants
|
11 Participants
|
11 Participants
|
15 Participants
|
18 Participants
|
11 Participants
|
9 Participants
|
5 Participants
|
20 Participants
|
14 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN with at least one FT3/FT4 test value < LLN (Lower Limit of Normal)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
7 Participants
|
14 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
10 Participants
|
8 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: From the start of the study treatment until disease progression, or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 144 months)Population: All treated participants for Cohort 2 only. Pre-specified to be reported for Cohort 2 only.
Objective response rate (ORR) is defined as the percent of all treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) by BICR per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=56 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=57 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=50 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
n=51 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) for Cohort 2
|
19.6 Percent of Participants
Interval 10.2 to 32.4
|
14.0 Percent of Participants
Interval 6.3 to 25.8
|
20.0 Percent of Participants
Interval 10.0 to 33.7
|
13.7 Percent of Participants
Interval 5.7 to 26.3
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
PRIMARY outcome
Timeframe: From the date of randomization (Cohort 3, 4, 6) or the date of first dose (Cohort 5) until disease progression, or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 144 months)Population: All treated participants for Cohorts 05, and all randomized participants for Cohorts 03, 04 and 06 only. Pre-specified to be reported for Cohorts 3 through 6.
Objective response rate (ORR) is defined as the percent of all treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=61 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=66 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=50 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
n=49 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
n=49 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
n=49 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
n=36 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
n=35 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) by Investigator for Cohorts 3, 4, 5, and 6
|
11.5 Percent of Participants
Interval 4.7 to 22.2
|
4.5 Percent of Participants
Interval 0.9 to 12.7
|
36.0 Percent of Participants
Interval 22.9 to 50.8
|
26.5 Percent of Participants
Interval 14.9 to 41.1
|
28.6 Percent of Participants
Interval 16.6 to 43.3
|
12.2 Percent of Participants
Interval 4.6 to 24.8
|
16.7 Percent of Participants
Interval 6.4 to 32.8
|
25.7 Percent of Participants
Interval 12.5 to 43.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the start of the study treatment until disease progression, or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 144 months)Population: All treated participants in Cohort 1; uninfected HCC, HCV-infected, and HBV-infected participants reported together as pre-specified.
Objective response rate (ORR) is defined as the percent of all treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) by BICR per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=23 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=10 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=15 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) for Cohort 1
|
13.0 Percent of Participants
Interval 2.8 to 33.6
|
20.0 Percent of Participants
Interval 2.5 to 55.6
|
13.3 Percent of Participants
Interval 1.7 to 40.5
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of randomization (Cohort 3, 4, 6) or the date of first dose (Cohort 1, 2, 5) up to approximately 144 months after first dosePopulation: All treated participants for Cohort 1, 2, and 5, and all randomized participants for Cohort 3, 4 and 6. Uninfected HCC, HCV-infected, and HBV-infected participants were pre-specified to be reported together for Cohort 1.
The number of participants whose best overall response (BOR) is CR in the population of interest. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=23 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=10 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=15 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
n=56 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
n=57 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
n=50 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
n=51 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
n=61 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
n=66 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
n=50 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
n=49 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
n=49 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
n=49 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
n=36 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
n=35 Participants
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Complete Response (CR) Assessed by Blinded Independent Central Review (BICR)
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of randomization (Cohort 3, 4, 6) or the date of first dose (Cohort 1, 2, 5) until disease progression, or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 144 months)Population: All treated participants for Cohort 1, 2, and 5, and all randomized participants for Cohort 3, 4 and 6. Uninfected HCC, HCV-infected, and HBV-infected participants were pre-specified to be reported together for Cohort 1.
The percentage of participants whose best overall response (BOR) is CR, PR or SD in the population of interest. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Failure to meet criteria for complete or partial response, in the absence of progressive disease. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=23 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=10 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=15 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
n=56 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
n=57 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
n=50 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
n=51 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
n=61 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
n=66 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
n=50 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
n=49 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
n=49 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
n=49 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
n=36 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
n=35 Participants
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR) Assessed by Blinded Independent Central Review (BICR)
|
47.8 Percent of Participants
Interval 26.8 to 69.4
|
70.0 Percent of Participants
Interval 34.8 to 93.3
|
40.0 Percent of Participants
Interval 16.3 to 67.7
|
66.1 Percent of Participants
Interval 52.2 to 78.2
|
56.1 Percent of Participants
Interval 42.4 to 69.3
|
54.0 Percent of Participants
Interval 39.3 to 68.2
|
47.1 Percent of Participants
Interval 32.9 to 61.5
|
52.5 Percent of Participants
Interval 39.3 to 65.4
|
62.1 Percent of Participants
Interval 49.3 to 73.8
|
54.0 Percent of Participants
Interval 39.3 to 68.2
|
42.9 Percent of Participants
Interval 28.8 to 57.8
|
49.0 Percent of Participants
Interval 34.4 to 63.7
|
44.9 Percent of Participants
Interval 30.7 to 59.8
|
77.8 Percent of Participants
Interval 60.8 to 89.9
|
80.0 Percent of Participants
Interval 63.1 to 91.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first documented response to first documented progression or death, whichever occurs first (Up to approximately 144 months)Population: All treated participants for Cohort 1, 2, and 5, and all randomized participants for Cohort 3, 4 and 6 whose best overall response (BOR) is either complete response (CR) or partial response (PR). Uninfected HCC, HCV-infected, and HBV-infected participants were pre-specified to be reported together for Cohort 1.
DOR is defined as the time from the first documented objective response (either complete or partial response) until the date of disease progression or death from any cause, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=2 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=2 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
n=11 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
n=8 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
n=10 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
n=7 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
n=8 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
n=4 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
n=16 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
n=16 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
n=15 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
n=3 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
n=5 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
n=10 Participants
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR) Assessed by Blinded Independent Central Review (BICR)
|
NA Months
Interval 8.74 to
Not estimable due to insufficient number of events
|
12.55 Months
Interval 5.75 to
Insufficient number of events to calculate UL
|
6.41 Months
Interval 2.83 to
Insufficient number of events to calculate UL
|
22.57 Months
Interval 5.62 to 31.8
|
11.30 Months
Interval 5.55 to
Insufficient number of events to calculate UL
|
NA Months
Interval 3.15 to
Not estimable due to insufficient number of events
|
NA Months
Interval 8.31 to
Not estimable due to insufficient number of events
|
5.21 Months
Interval 2.1 to
Insufficient number of events to calculate UL
|
9.26 Months
Interval 5.45 to
Insufficient number of events to calculate UL
|
17.48 Months
Interval 8.31 to 52.47
|
22.21 Months
Interval 9.36 to
Insufficient number of events to calculate UL
|
16.59 Months
Interval 4.34 to 48.2
|
18.40 Months
Insufficient number of events to calculate LL and UL
|
21.55 Months
Interval 10.84 to
Insufficient number of events to calculate UL
|
49.51 Months
Interval 7.72 to
Insufficient number of events to calculate UL
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of randomization (Cohort 3, 4, 6) or the date of first dose (Cohort 1, 2, 5) to the date of attainment of complete response (CR) or partial response (PR) (up to approximately 144 months)Population: All treated participants for Cohort 1, 2, and 5, and all randomized participants for Cohort 3, 4 and 6 whose best overall response (BOR) is either complete response (CR) or partial response (PR). Uninfected HCC, HCV-infected, and HBV-infected participants were pre-specified to be reported together for Cohort 1.
Time to Response (TTR) defined as the time from randomization to the date of the first confirmed CR or PR for Cohort 3, 4 and 6, and from the first dosing date of study medication to the date of the first confirmed CR or PR for cohort 1, 2 and 5. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=2 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=2 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
n=11 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
n=8 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
n=10 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
n=7 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
n=8 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
n=4 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
n=16 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
n=16 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
n=15 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
n=3 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
n=5 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
n=10 Participants
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Response (TTR) Assessed by Blinded Independent Central Review (BICR)
|
1.41 Months
Interval 1.4 to 2.8
|
3.15 Months
Interval 2.3 to 4.0
|
1.99 Months
Interval 1.3 to 2.7
|
2.73 Months
Interval 1.3 to 6.8
|
3.63 Months
Interval 2.6 to 5.7
|
2.78 Months
Interval 1.2 to 7.0
|
1.38 Months
Interval 1.2 to 6.8
|
3.50 Months
Interval 1.9 to 5.7
|
2.81 Months
Interval 1.9 to 5.5
|
2.00 Months
Interval 1.1 to 12.8
|
2.58 Months
Interval 1.2 to 5.5
|
2.66 Months
Interval 1.2 to 8.7
|
2.66 Months
Interval 1.4 to 4.2
|
5.13 Months
Interval 1.3 to 5.7
|
4.17 Months
Interval 1.3 to 8.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of randomization (Cohort 3, 4, 6) or the date of first dose (Cohort 1, 2, 5) up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 144 months)Population: All treated participants for Cohort 1, 2, and 5, and all randomized participants for Cohort 3, 4 and 6. Uninfected HCC, HCV-infected, and HBV-infected participants were pre-specified to be reported together for Cohort 1.
Time to Progression (TTP) is defined from the date of randomization (Cohort 3, 4, 6) or the date of first dose (Cohort 1, 2, 5) to the date of the first objectively documented disease progression. Participants who have not progressed as assessed by radiography will be censored at the last tumor assessment date prior to subsequent anti-cancer therapy. Participants who have no on-study tumor assessments were censored at the date of randomization. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=23 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=10 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=15 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
n=56 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
n=57 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
n=50 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
n=51 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
n=61 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
n=66 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
n=50 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
n=49 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
n=49 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
n=49 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
n=36 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
n=35 Participants
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Progression (TTP) Assessed by Blinded Independent Central Review (BICR)
|
2.66 Months
Interval 1.38 to 4.21
|
8.21 Months
Interval 1.31 to
Insufficient number of events to calculate UL
|
2.96 Months
Interval 1.25 to 6.97
|
4.01 Months
Interval 2.76 to 4.63
|
2.79 Months
Interval 1.48 to 5.59
|
3.94 Months
Interval 2.63 to 8.05
|
2.63 Months
Interval 1.38 to 4.04
|
4.83 Months
Interval 1.94 to 5.55
|
4.63 Months
Interval 3.32 to 12.94
|
4.27 Months
Interval 2.63 to 9.69
|
1.68 Months
Interval 1.35 to 13.9
|
2.73 Months
Interval 1.45 to 5.65
|
2.79 Months
Interval 1.41 to 5.36
|
5.42 Months
Interval 2.76 to 11.47
|
11.63 Months
Interval 4.11 to 36.86
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 6 and 12 monthsPopulation: All treated participants for Cohort 1, 2, and 5, and all randomized participants for Cohort 3, 4 and 6. Uninfected HCC, HCV-infected, and HBV-infected participants were pre-specified to be reported together for Cohort 1.
TTP rate is defined as the percentage of participants without disease progression at select time points (milestones) during the study. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=23 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=10 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=15 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
n=56 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
n=57 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
n=50 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
n=51 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
n=61 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
n=66 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
n=50 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
n=49 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
n=49 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
n=49 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
n=36 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
n=35 Participants
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Progression (TTP) Rate Assessed by Blinded Independent Central Review (BICR)
6 Months
|
28.6 Percent of Participants
Interval 11.7 to 48.2
|
60.0 Percent of Participants
Interval 25.3 to 82.7
|
27.9 Percent of Participants
Interval 7.1 to 54.1
|
33.9 Percent of Participants
Interval 21.4 to 46.9
|
32.8 Percent of Participants
Interval 20.2 to 46.0
|
41.5 Percent of Participants
Interval 26.9 to 55.5
|
26.0 Percent of Participants
Interval 14.7 to 38.9
|
30.1 Percent of Participants
Interval 17.3 to 44.0
|
42.5 Percent of Participants
Interval 27.2 to 56.9
|
42.5 Percent of Participants
Interval 28.0 to 56.3
|
43.6 Percent of Participants
Interval 28.7 to 57.5
|
32.4 Percent of Participants
Interval 19.3 to 46.2
|
31.6 Percent of Participants
Interval 16.9 to 47.4
|
42.8 Percent of Participants
Interval 25.2 to 59.3
|
50.0 Percent of Participants
Interval 30.3 to 66.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Progression (TTP) Rate Assessed by Blinded Independent Central Review (BICR)
12 Months
|
17.1 Percent of Participants
Interval 4.6 to 36.5
|
24.0 Percent of Participants
Interval 3.8 to 53.7
|
18.6 Percent of Participants
Interval 3.0 to 44.5
|
21.4 Percent of Participants
Interval 11.3 to 33.6
|
19.3 Percent of Participants
Interval 9.0 to 32.4
|
30.9 Percent of Participants
Interval 17.7 to 45.1
|
13.0 Percent of Participants
Interval 5.3 to 24.2
|
12.2 Percent of Participants
Interval 4.1 to 25.0
|
35.4 Percent of Participants
Interval 20.5 to 50.6
|
33.1 Percent of Participants
Interval 19.8 to 46.9
|
35.9 Percent of Participants
Interval 21.9 to 50.1
|
27.6 Percent of Participants
Interval 15.4 to 41.3
|
14.7 Percent of Participants
Interval 4.4 to 31.0
|
32.1 Percent of Participants
Interval 16.5 to 48.9
|
45.0 Percent of Participants
Interval 25.5 to 62.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of randomization (Cohort 3, 4, 6) or the date of first dose (Cohort 1, 2, 5) up to documented disease progression or death, whichever occurs first (up to approximately 144 months)Population: All treated participants for Cohort 1, 2, and 5, and all randomized participants for Cohort 3, 4 and 6. Uninfected HCC, HCV-infected, and HBV-infected participants were pre-specified to be reported together for Cohort 1.
PFS is defined as the time from randomization date or first dosing date of study medication to the date of the first objectively documented tumor progression or death due to any cause. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last tumor assessment. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=23 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=10 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=15 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
n=56 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
n=57 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
n=50 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
n=51 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
n=61 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
n=66 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
n=50 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
n=49 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
n=49 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
n=49 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
n=36 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
n=35 Participants
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR)
|
2.69 Months
Interval 1.38 to 4.21
|
8.97 Months
Interval 1.31 to 14.06
|
2.96 Months
Interval 1.25 to 4.07
|
4.01 Months
Interval 2.76 to 4.6
|
2.76 Months
Interval 1.48 to 4.4
|
3.94 Months
Interval 2.63 to 7.23
|
2.63 Months
Interval 1.35 to 4.04
|
3.78 Months
Interval 1.84 to 5.45
|
3.91 Months
Interval 3.32 to 5.65
|
3.91 Months
Interval 2.6 to 8.31
|
1.61 Months
Interval 1.35 to 6.93
|
2.63 Months
Interval 1.31 to 4.5
|
2.30 Months
Interval 1.41 to 3.42
|
5.13 Months
Interval 2.76 to 10.91
|
4.27 Months
Interval 3.58 to 11.86
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of randomization (Cohort 3, 4, 6) or the date of first dose (Cohort 1, 2, 5) up to the date of death or date last known alive (up to approximately 144 months)Population: All treated participants for Cohort 1, 2, and 5, and all randomized participants for Cohort 3, 4 and 6. Uninfected HCC, HCV-infected, and HBV-infected participants were pre-specified to be reported together for Cohort 1.
OS is defined as the time from randomization date or first dosing date of study medication to the date of death (due to any cause). Participants who were alive were censored at the last known alive dates.
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=23 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=10 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=15 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
n=56 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
n=57 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
n=50 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
n=51 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
n=61 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
n=66 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
n=50 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
n=49 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
n=49 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
n=49 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
n=36 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
n=35 Participants
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
14.32 Months
Interval 5.65 to 18.14
|
36.27 Months
Interval 3.61 to 55.1
|
10.45 Months
Interval 3.68 to 20.21
|
26.68 Months
Interval 17.71 to 34.4
|
13.44 Months
Interval 8.57 to 18.89
|
17.45 Months
Interval 13.04 to 25.66
|
15.64 Months
Interval 9.69 to 20.67
|
15.24 Months
Interval 11.07 to 22.9
|
13.96 Months
Interval 8.71 to 19.25
|
22.24 Months
Interval 9.43 to 54.83
|
12.48 Months
Interval 7.62 to 16.39
|
12.75 Months
Interval 7.43 to 30.52
|
7.85 Months
Interval 4.37 to 10.51
|
20.21 Months
Interval 13.11 to 32.2
|
22.11 Months
Interval 15.15 to 36.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 6, 12, 24, 48 and 60 monthsPopulation: All treated participants for Cohort 1, 2, and 5, and all randomized participants for Cohort 3, 4 and 6. Uninfected HCC, HCV-infected, and HBV-infected participants were pre-specified to be reported together for Cohort 1.
OS rate is defined as the percentage of participants who are still alive at certain time points during the study.
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=23 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=10 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=15 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
n=56 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
n=57 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
n=50 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
n=51 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
n=61 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
n=66 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
n=50 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
n=49 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
n=49 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
n=49 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
n=36 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
n=35 Participants
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) Rate
24 Months
|
26.1 Percent of Participants
Interval 10.6 to 44.7
|
60.0 Percent of Participants
Interval 25.3 to 82.7
|
26.7 Percent of Participants
Interval 8.3 to 49.6
|
57.0 Percent of Participants
Interval 42.7 to 69.0
|
26.3 Percent of Participants
Interval 15.7 to 38.1
|
38.9 Percent of Participants
Interval 24.5 to 53.0
|
36.6 Percent of Participants
Interval 23.6 to 49.7
|
32.9 Percent of Participants
Interval 21.3 to 45.0
|
30.4 Percent of Participants
Interval 18.8 to 42.8
|
46.1 Percent of Participants
Interval 31.7 to 59.3
|
30.2 Percent of Participants
Interval 17.9 to 43.5
|
42.3 Percent of Participants
Interval 28.3 to 55.7
|
10.2 Percent of Participants
Interval 3.7 to 20.5
|
39.0 Percent of Participants
Interval 22.6 to 55.2
|
46.1 Percent of Participants
Interval 28.7 to 61.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Overall Survival (OS) Rate
48 Months
|
17.4 Percent of Participants
Interval 5.4 to 35.0
|
30.0 Percent of Participants
Interval 7.1 to 57.8
|
6.7 Percent of Participants
Interval 0.4 to 26.0
|
20.9 Percent of Participants
Interval 11.2 to 32.7
|
11.7 Percent of Participants
Interval 4.9 to 21.7
|
14.6 Percent of Participants
Interval 6.0 to 26.9
|
12.2 Percent of Participants
Interval 5.0 to 22.9
|
15.6 Percent of Participants
Interval 7.5 to 26.5
|
8.4 Percent of Participants
Interval 2.7 to 18.0
|
37.0 Percent of Participants
Interval 23.5 to 50.6
|
21.6 Percent of Participants
Interval 11.2 to 34.2
|
25.4 Percent of Participants
Interval 14.2 to 38.2
|
00 Percent of Participants
Interval 0.0 to 0.0
|
19.0 Percent of Participants
Interval 7.5 to 34.4
|
30.7 Percent of Participants
Interval 16.1 to 46.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Overall Survival (OS) Rate
60 Months
|
8.7 Percent of Participants
Interval 1.5 to 24.2
|
15.0 Percent of Participants
Interval 1.0 to 45.7
|
6.7 Percent of Participants
Interval 0.4 to 26.0
|
15.2 Percent of Participants
Interval 7.1 to 26.1
|
9.7 Percent of Participants
Interval 3.7 to 19.3
|
14.6 Percent of Participants
Interval 6.0 to 26.9
|
12.2 Percent of Participants
Interval 5.0 to 22.9
|
8.9 Percent of Participants
Interval 3.0 to 18.8
|
5.6 Percent of Participants
Interval 1.2 to 15.1
|
29.6 Percent of Participants
Interval 17.1 to 43.2
|
19.2 Percent of Participants
Interval 9.4 to 31.6
|
21.2 Percent of Participants
Interval 11.0 to 33.6
|
00 Percent of Participants
Interval 0.0 to 0.0
|
15.2 Percent of Participants
Interval 5.1 to 30.2
|
24.6 Percent of Participants
Interval 11.6 to 40.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Overall Survival (OS) Rate
12 Months
|
60.9 Percent of Participants
Interval 38.3 to 77.4
|
80.0 Percent of Participants
Interval 40.9 to 94.6
|
46.7 Percent of Participants
Interval 21.2 to 68.7
|
76.0 Percent of Participants
Interval 62.3 to 85.3
|
54.4 Percent of Participants
Interval 40.7 to 66.2
|
67.5 Percent of Participants
Interval 51.9 to 79.0
|
58.8 Percent of Participants
Interval 44.1 to 70.9
|
57.1 Percent of Participants
Interval 43.4 to 68.6
|
57.0 Percent of Participants
Interval 43.2 to 68.6
|
60.7 Percent of Participants
Interval 45.6 to 72.9
|
56.1 Percent of Participants
Interval 41.0 to 68.8
|
50.8 Percent of Participants
Interval 36.1 to 63.7
|
34.7 Percent of Participants
Interval 21.8 to 47.9
|
70.2 Percent of Participants
Interval 51.6 to 82.7
|
70.6 Percent of Participants
Interval 52.3 to 83.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Overall Survival (OS) Rate
6 Months
|
69.6 Percent of Participants
Interval 46.6 to 84.2
|
80.0 Percent of Participants
Interval 40.9 to 94.6
|
53.3 Percent of Participants
Interval 26.3 to 74.4
|
89.0 Percent of Participants
Interval 77.0 to 94.9
|
75.4 Percent of Participants
Interval 62.1 to 84.7
|
83.3 Percent of Participants
Interval 69.3 to 91.3
|
84.3 Percent of Participants
Interval 71.1 to 91.8
|
81.3 Percent of Participants
Interval 68.8 to 89.2
|
76.7 Percent of Participants
Interval 63.8 to 85.5
|
81.7 Percent of Participants
Interval 67.7 to 90.0
|
75.0 Percent of Participants
Interval 60.2 to 85.0
|
73.5 Percent of Participants
Interval 58.7 to 83.6
|
59.2 Percent of Participants
Interval 44.2 to 71.4
|
82.4 Percent of Participants
Interval 64.9 to 91.7
|
82.4 Percent of Participants
Interval 65.0 to 91.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Cycle 1 Day 1 and Cycle 3 Day 1 (Each Cycle = 2 Weeks)Population: All treated participants in Cohort 1 with baseline and at least 1 post-baseline assessment; uninfected HCC, HCV-infected, and HBV-infected participants reported together as pre-specified.
Cmax is the maximum observed serum concentration.
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=23 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=10 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=15 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax)
Cycle 1 Day 1
|
60.06 ug/mL
Geometric Coefficient of Variation 335.87
|
19.81 ug/mL
Geometric Coefficient of Variation 109.88
|
9.82 ug/mL
Geometric Coefficient of Variation 244.81
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed Serum Concentration (Cmax)
Cycle 3 Day 1
|
100.74 ug/mL
Geometric Coefficient of Variation 339.27
|
23.09 ug/mL
Geometric Coefficient of Variation 130.66
|
15.54 ug/mL
Geometric Coefficient of Variation 379.81
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Cycle 1 Day 1 and Cycle 3 Day 1 (Each Cycle = 2 Weeks)Population: All treated participants in Cohort 1 with baseline and at least 1 post-baseline assessment; uninfected HCC, HCV-infected, and HBV-infected participants reported together as pre-specified.
Tmax is the time taken to reach the maximum observed serum concentration (Cmax).
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=23 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=10 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=15 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time of Maximum Observed Serum Concentration (Tmax)
Cycle 1 Day 1
|
3.00 Hour
Interval 1.0 to 25.2
|
2.98 Hour
Interval 0.9 to 25.2
|
3.00 Hour
Interval 0.9 to 23.9
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Time of Maximum Observed Serum Concentration (Tmax)
Cycle 3 Day 1
|
12.75 Hour
Interval 0.9 to 24.3
|
12.28 Hour
Interval 1.0 to 24.5
|
24.13 Hour
Interval 0.8 to 25.7
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: At Cycle 1 Day 1 and Cycle 3 Day 1 (Each Cycle = 2 Weeks)Population: All treated participants in Cohort 1 with baseline and at least 1 post-baseline assessment; uninfected HCC, HCV-infected, and HBV-infected participants reported together as pre-specified.
AUC (TAU) is the area measured under the concentration-time curve taken over the dosing interval.
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=21 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=9 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=15 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration Time Curve in the Dosing Interval [AUC(TAU)]
Cycle 1 Day 1
|
9114.43 ug.h/mL
Geometric Coefficient of Variation 366.71
|
2825.09 ug.h/mL
Geometric Coefficient of Variation 159.47
|
1313.76 ug.h/mL
Geometric Coefficient of Variation 287.76
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
—
|
|
Area Under the Serum Concentration Time Curve in the Dosing Interval [AUC(TAU)]
Cycle 3 Day 1
|
15229.27 ug.h/mL
Geometric Coefficient of Variation 383.94
|
3358.78 ug.h/mL
Geometric Coefficient of Variation 79.68
|
3731.16 ug.h/mL
Geometric Coefficient of Variation 505.00
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Cycle 1 Day 1 and Cycle 3 Day 1 (Each Cycle = 2 Weeks)Population: All treated participants in Cohort 1 with baseline and at least 1 post-baseline assessment; uninfected HCC, HCV-infected, and HBV-infected participants reported together as pre-specified.
Ctrough is the lowest observed serum concentration.
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=21 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=9 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=15 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum Concentration Achieved at the End of Dosing Interval (Trough Concentration) (Ctrough)
Cycle 1 Day 1
|
16.52 ug/mL
Geometric Coefficient of Variation 383.95
|
4.40 ug/mL
Geometric Coefficient of Variation 194.65
|
2.26 ug/mL
Geometric Coefficient of Variation 412.75
|
—
|
—
|
—
|
—
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—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentration Achieved at the End of Dosing Interval (Trough Concentration) (Ctrough)
Cycle 3 Day 1
|
32.48 ug/mL
Geometric Coefficient of Variation 430.86
|
6.76 ug/mL
Geometric Coefficient of Variation 97.21
|
8.51 ug/mL
Geometric Coefficient of Variation 473.58
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Cycle 1 Day 1 and Cycle 3 Day 1 (Each Cycle = 2 Weeks)Population: All treated participants in Cohort 1 with baseline and at least 1 post-baseline assessment; uninfected HCC, HCV-infected, and HBV-infected participants reported together as pre-specified.
Serum Concentration Achieved at the End of the Infusion (Ceoinf) refers to the amount of drug present in the blood (serum) immediately after the completion of an infusion. It represents the concentration measured at the exact time the infusion ends, before any significant elimination or distribution occurs.
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=23 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=10 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=14 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum Concentration Achieved at the End of the Infusion (Ceoinf)
Cycle 3 Day 1
|
84.36 ug/mL
Geometric Coefficient of Variation 371.92
|
25.53 ug/mL
Geometric Coefficient of Variation 147.16
|
11.80 ug/mL
Geometric Coefficient of Variation 353.06
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serum Concentration Achieved at the End of the Infusion (Ceoinf)
Cycle 1 Day 1
|
49.88 ug/mL
Geometric Coefficient of Variation 315.39
|
17.07 ug/mL
Geometric Coefficient of Variation 123.95
|
6.99 ug/mL
Geometric Coefficient of Variation 254.53
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Cycle 3 Day 1 (Each Cycle = 2 Weeks)Population: All treated participants in Cohort 1 with baseline and at least 1 post-baseline assessment; uninfected HCC, HCV-infected, and HBV-infected participants reported together as pre-specified.
AI\_Cmax is ratio of an exposure measure at steady state to that after the first dose (exposure measure includes Cmax)
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=8 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=6 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax)
|
2.26 Ratio
Geometric Coefficient of Variation 69.85
|
1.53 Ratio
Geometric Coefficient of Variation 23.34
|
1.45 Ratio
Geometric Coefficient of Variation 23.94
|
—
|
—
|
—
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—
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—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Cycle 3 Day 1 (Each Cycle = 2 Weeks)Population: All treated participants in Cohort 1 with baseline and at least 1 post-baseline assessment; uninfected HCC, HCV-infected, and HBV-infected participants reported together as pre-specified.
AI\_AUC is accumulation index ratio of AUC at steady state to that after the first dose
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=6 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=5 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC)
|
2.60 Ratio
Geometric Coefficient of Variation 24.54
|
2.23 Ratio
Geometric Coefficient of Variation 9.80
|
2.28 Ratio
Geometric Coefficient of Variation 8.90
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Cycle 3 Day 1 (Each Cycle = 2 Weeks)Population: All treated participants in Cohort 1 with baseline and at least 1 post-baseline assessment; uninfected HCC, HCV-infected, and HBV-infected participants reported together as pre-specified.
Effective half-life is defined as the time it takes for the amount of a drug in the body to decrease by half.
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=6 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=5 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Effective T-Half (T-HALF)
|
468.07 Hour
Geometric Coefficient of Variation 27.65
|
382.36 Hour
Geometric Coefficient of Variation 15.52
|
406.60 Hour
Geometric Coefficient of Variation 15.65
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study medication through 100 days following last dose of study treatment (Assessed approximately 04 months up to a max of approximately 106 months)Population: All treated participants in Cohort 1 and 2 with baseline and at least 1 post-baseline assessment. Pre-specified to be reported for Cohort 1 and 2 only.
Baseline ADA Positive: Participant with baseline ADA-positive sample ADA Positive: Participant with at least one ADA-positive sample relative to baseline Persistent Positive (PP): ADA-positive sample at 2 or more consecutive timepoints Not PP-Last Sample Positive: Not persistent but with ADA-positive sample at the last sampling timepoint Other Positive: Not persistent but some ADA-positive samples with the last sample being negative ADA Negative: Participant with no ADA-positive sample after initiation of treatment
Outcome measures
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=1 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
n=3 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
n=12 Participants
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
n=3 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
n=4 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
n=3 Participants
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
n=5 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
n=3 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
n=3 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
n=4 Participants
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
n=53 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
n=54 Participants
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HCV Infected: Treatment 3
n=44 Participants
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2 HBV Infected: Treatment 4
n=50 Participants
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Anti-drug Antibodies (ADA)
Baseline ADA Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
10 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADA)
ADA Positive
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
18 Participants
|
19 Participants
|
16 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADA)
ADA Positive [Persistent Positive (PP)]
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADA)
ADA Positive [Not PP-Last Sample Positive]
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
9 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADA)
ADA Positive [Other Positive]
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
12 Participants
|
15 Participants
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADA)
Neutralizing Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADA)
ADA Negative
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
11 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
35 Participants
|
35 Participants
|
28 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1 Uninfected HCC: Treatment 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Cohort 1 Uninfected HCC: Treatment 2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort 1 Uninfected HCC: Treatment 3
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Cohort 1 Uninfected HCC: Treatment 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Cohort 1 Uninfected HCC: Treatment 5
Serious events: 8 serious events
Other events: 13 other events
Deaths: 13 deaths
Cohort 1 HCV Infected: Treatment 6
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort 1 HCV Infected: Treatment 7
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
Cohort 1 HCV Infected: Treatment 8
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort 1 HBV Infected: Treatment 9
Serious events: 5 serious events
Other events: 5 other events
Deaths: 5 deaths
Cohort 1 HBV Infected: Treatment 10
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort 1 HBV Infected: Treatment 11
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort 1 HBV Infected: Treatment 12
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
Cohort 2: Nivolumab 3 mg/kg
Serious events: 137 serious events
Other events: 210 other events
Deaths: 186 deaths
Cohort 3: Treatment 1
Serious events: 35 serious events
Other events: 55 other events
Deaths: 52 deaths
Cohort 3: Treatment 2
Serious events: 33 serious events
Other events: 57 other events
Deaths: 53 deaths
Cohort 4: Treatment 1
Serious events: 35 serious events
Other events: 47 other events
Deaths: 36 deaths
Cohort 4: Treatment 2
Serious events: 36 serious events
Other events: 47 other events
Deaths: 41 deaths
Cohort 4: Treatment 3
Serious events: 36 serious events
Other events: 45 other events
Deaths: 41 deaths
Cohort 5: Treatment 1
Serious events: 37 serious events
Other events: 42 other events
Deaths: 48 deaths
Cohort 6: Treatment 1
Serious events: 22 serious events
Other events: 36 other events
Deaths: 29 deaths
Cohort 6: Treatment 2
Serious events: 25 serious events
Other events: 35 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=1 participants at risk
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=3 participants at risk
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=3 participants at risk
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
n=3 participants at risk
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
n=13 participants at risk
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
n=3 participants at risk
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
n=4 participants at risk
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
n=3 participants at risk
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
n=5 participants at risk
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
n=3 participants at risk
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
n=3 participants at risk
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
n=4 participants at risk
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2: Nivolumab 3 mg/kg
n=214 participants at risk
Participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
n=60 participants at risk
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
n=62 participants at risk
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
n=49 participants at risk
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
n=49 participants at risk
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
n=48 participants at risk
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
n=49 participants at risk
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
n=36 participants at risk
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
n=35 participants at risk
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.4%
3/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Endocrine disorders
Immune-mediated hypophysitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Eye disorders
Diplopia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.3%
5/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.0%
3/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.8%
3/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Asthenia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
50.0%
2/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.9%
4/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
9.7%
6/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.2%
3/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Autoimmune enteropathy
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Femoral hernia incarcerated
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.9%
4/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.8%
3/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Malignant ascites
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.9%
4/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.8%
3/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Death
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
General physical health deterioration
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.3%
5/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Generalised oedema
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Hernia pain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Influenza like illness
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Injection site reaction
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Malaise
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Pain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Peripheral swelling
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
7/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.2%
4/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
4/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
3/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Sudden death
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Cholangitis sclerosing
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Hepatitis cholestatic
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Hepatorenal failure
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Immune system disorders
Type IV hypersensitivity reaction
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Bronchitis pneumococcal
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Vascular disorders
Embolism
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Cystitis escherichia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Device related infection
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Infection
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Influenza
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Listeriosis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Pleurisy bacterial
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
7/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.2%
3/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.2%
3/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Septic shock
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Spontaneous bacterial peritonitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Systemic infection
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Viral infection
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Wound infection
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Depressed fracture
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Hepatic rupture
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.9%
4/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Ammonia increased
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.9%
4/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
12.2%
6/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Inflammatory marker increased
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Liver function test increased
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.4%
3/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.9%
4/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acral lentiginous melanoma
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver carcinoma ruptured
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
30.8%
4/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
50.0%
2/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
75.0%
3/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
24.3%
52/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.7%
10/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.1%
10/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
24.5%
12/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
30.6%
15/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
37.5%
18/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
36.7%
18/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.7%
6/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
14.3%
5/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.4%
3/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Arachnoid cyst
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Intracranial tumour haemorrhage
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Quadriplegia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Seizure
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.2%
2/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.4%
3/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.4%
3/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Social circumstances
Loss of personal independence in daily activities
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Vascular disorders
Bleeding varicose vein
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Vascular disorders
Haematoma
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Vascular disorders
Shock
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
Other adverse events
| Measure |
Cohort 1 Uninfected HCC: Treatment 1
n=1 participants at risk
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 2
n=3 participants at risk
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 3
n=3 participants at risk
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 4
n=3 participants at risk
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 Uninfected HCC: Treatment 5
n=13 participants at risk
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 6
n=3 participants at risk
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 7
n=4 participants at risk
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HCV Infected: Treatment 8
n=3 participants at risk
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 9
n=5 participants at risk
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 10
n=3 participants at risk
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 11
n=3 participants at risk
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
|
Cohort 1 HBV Infected: Treatment 12
n=4 participants at risk
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 2: Nivolumab 3 mg/kg
n=214 participants at risk
Participants received nivolumab 3 mg/kg every 2 weeks
|
Cohort 3: Treatment 1
n=60 participants at risk
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
|
Cohort 3: Treatment 2
n=62 participants at risk
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
|
Cohort 4: Treatment 1
n=49 participants at risk
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
|
Cohort 4: Treatment 2
n=49 participants at risk
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
|
Cohort 4: Treatment 3
n=48 participants at risk
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
|
Cohort 5: Treatment 1
n=49 participants at risk
Participants received nivolumab 240 mg every 2 weeks
|
Cohort 6: Treatment 1
n=36 participants at risk
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
|
Cohort 6: Treatment 2
n=35 participants at risk
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
23.1%
3/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
50.0%
2/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
19.6%
42/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
5/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
12.9%
8/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
12.2%
6/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
22.4%
11/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
22.9%
11/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.3%
8/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.7%
6/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.4%
3/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
50.0%
2/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.4%
3/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.0%
15/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.8%
3/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.9%
4/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.2%
2/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.6%
3/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
4/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.9%
4/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.2%
5/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.2%
3/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.4%
4/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.7%
10/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.0%
3/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
22.4%
11/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.2%
5/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
12.5%
6/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
19.4%
7/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
14.3%
5/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Eye disorders
Dry eye
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.9%
4/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.2%
4/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Eye disorders
Pterygium
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Eye disorders
Vision blurred
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
6/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.8%
3/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Eye disorders
Visual impairment
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
40.0%
2/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
14.0%
30/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.7%
7/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.2%
4/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
12.5%
6/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.2%
4/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
50.0%
2/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
23.8%
51/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
23.3%
14/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
22.6%
14/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
14.3%
7/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
30.6%
15/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
14.6%
7/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
14.3%
7/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.1%
4/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
14.3%
5/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.4%
3/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.2%
24/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.7%
7/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.5%
4/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.3%
8/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.2%
5/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
4/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.6%
3/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Ascites
|
100.0%
1/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
75.0%
3/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.3%
22/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.0%
6/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.1%
10/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.3%
8/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
12.2%
6/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.7%
8/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
36.7%
18/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.7%
6/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.6%
3/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
23.1%
3/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
50.0%
2/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
18.7%
40/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
18.3%
11/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.1%
10/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
18.4%
9/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
22.4%
11/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
12/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.1%
4/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
7/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
1/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
30.8%
4/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
100.0%
3/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
50.0%
2/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
28.5%
61/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
18.3%
11/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
51.6%
32/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
38.8%
19/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
22.4%
11/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
39.6%
19/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
18.4%
9/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
58.3%
21/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
42.9%
15/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.7%
23/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.5%
4/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
12.2%
6/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.2%
4/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.2%
3/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
14.3%
5/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
13/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
12.2%
6/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.2%
4/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.2%
3/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.3%
5/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Gastric varices
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.9%
4/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.1%
4/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.9%
4/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.1%
4/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Asthenia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.7%
8/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
5/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
9.7%
6/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.2%
5/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
12.2%
6/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.4%
5/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
14.3%
7/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.7%
6/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
7/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.2%
2/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
6/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.2%
2/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.2%
2/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
30.8%
4/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.1%
43/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.7%
10/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
21.0%
13/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.4%
10/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
26.5%
13/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
22.9%
11/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
13.9%
5/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
14.3%
5/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Neurogenic bowel
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
50.0%
2/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.1%
11/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.0%
3/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.1%
5/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
12.2%
6/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.2%
3/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.9%
4/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
1/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
23.1%
3/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
17.3%
37/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
13.3%
8/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
9.7%
6/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
12.2%
6/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.4%
10/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
14.6%
7/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
13.9%
5/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
7/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Chest discomfort
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.4%
3/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Chills
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
7/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.2%
2/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.2%
5/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Discomfort
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
38.5%
5/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
75.0%
3/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
40.0%
2/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
40.2%
86/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
38.3%
23/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.9%
21/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
22.4%
11/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
22.4%
11/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
27.1%
13/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.2%
5/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
27.8%
10/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
31.4%
11/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Influenza like illness
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.9%
19/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
14.3%
7/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
12.2%
6/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.4%
5/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Infusion site swelling
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Malaise
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
13/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
14.3%
7/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.2%
5/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
12.5%
6/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.6%
3/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Mass
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.7%
8/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.0%
3/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.5%
4/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
3/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.6%
3/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
7/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Oedema peripheral
|
100.0%
1/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
50.0%
2/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.4%
35/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
13.3%
8/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.3%
7/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.4%
10/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
22.4%
11/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
29.2%
14/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
26.5%
13/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.1%
4/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
7/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Pain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.0%
15/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.0%
3/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.2%
3/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
50.0%
2/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
18.7%
40/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
15/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
17.7%
11/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
28.6%
14/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
30.6%
15/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
39.6%
19/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.3%
8/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
27.8%
10/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.7%
9/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
6/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.2%
2/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
3/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
14.3%
5/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.4%
3/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.5%
4/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.3%
5/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.2%
3/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.6%
3/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.2%
3/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Furuncle
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Impetigo
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Influenza
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
6/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.2%
5/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.4%
4/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Nasal herpes
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.5%
14/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.8%
3/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.2%
5/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
6/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.2%
2/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.6%
3/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.4%
3/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.2%
4/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Pustule
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.4%
3/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.2%
2/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Skin infection
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
100.0%
3/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
60.0%
3/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
13/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
12.2%
6/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Lipase increased
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
50.0%
2/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.4%
18/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.0%
3/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.5%
4/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
18.4%
9/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
14.3%
7/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
18.8%
9/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.2%
5/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.1%
4/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.7%
9/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.7%
10/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.4%
3/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.3%
5/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
6/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.2%
4/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
23.1%
3/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.8%
36/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
15.0%
9/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.3%
7/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
30.6%
15/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
22.4%
11/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
18.8%
9/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.7%
6/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
42.9%
15/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Amylase increased
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
23.1%
3/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
50.0%
2/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
9.3%
20/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.8%
3/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.2%
5/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.2%
5/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
4/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.2%
4/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
7/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
1/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
30.8%
4/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
50.0%
2/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
40.0%
2/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
17.8%
38/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.7%
10/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.1%
10/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
34.7%
17/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
32.7%
16/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
22.9%
11/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
12.2%
6/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
27.8%
10/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
42.9%
15/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Blood alkaline phosphatase increased
|
100.0%
1/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
40.0%
2/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
12/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.0%
3/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.1%
5/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
12.2%
6/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.4%
5/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
3/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
17.1%
6/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
50.0%
2/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.9%
19/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.7%
7/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.3%
7/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.4%
10/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
14.3%
7/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
12.2%
6/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
13.9%
5/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
14.3%
5/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
6/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.0%
3/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.2%
4/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
3/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Cortisol decreased
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.4%
3/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.2%
5/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.7%
4/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.8%
3/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Glucose urine present
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.3%
5/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.2%
4/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.2%
3/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.4%
4/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
40.0%
2/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
13/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.0%
3/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.5%
4/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.4%
10/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.1%
4/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
7/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Transaminases increased
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Waist circumference increased
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
38.5%
5/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
50.0%
2/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.9%
17/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
17.7%
11/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
22.4%
11/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
12.2%
6/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.4%
5/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
13.9%
5/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
17.1%
6/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
Weight increased
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.9%
4/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.9%
4/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
100.0%
1/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
30.8%
4/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
75.0%
3/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
40.0%
2/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
75.0%
3/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
26.6%
57/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
12/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
35.5%
22/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
40.8%
20/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
26.5%
13/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
31.2%
15/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
22.2%
8/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
22.9%
8/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.3%
5/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
4/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
3/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.9%
4/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
23.1%
3/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
50.0%
2/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.0%
15/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.0%
6/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.5%
4/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
12.5%
6/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.4%
3/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.0%
3/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.2%
4/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
50.0%
2/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
50.0%
2/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.0%
15/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
5/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.1%
5/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.2%
5/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.4%
5/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
3/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.4%
4/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.8%
3/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.3%
5/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
6/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.8%
3/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.2%
4/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.2%
5/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
12.5%
6/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
9/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.8%
3/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.2%
3/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
13.9%
5/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
100.0%
1/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
75.0%
3/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
7/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
13.3%
8/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.8%
3/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
18.4%
9/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.2%
4/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
12.5%
6/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.6%
3/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
75.0%
3/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
13/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
12.9%
8/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
3/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
17.8%
38/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
5/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.1%
5/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
18.4%
9/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.4%
10/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
14.6%
7/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.2%
4/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.7%
6/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.6%
3/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.9%
4/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
23.1%
3/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
50.0%
2/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
50.0%
2/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
17.3%
37/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
15.0%
9/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.1%
10/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.3%
8/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.8%
10/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.1%
4/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
14.3%
5/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.6%
3/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.4%
3/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.0%
3/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.1%
5/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
3/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.3%
5/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
9/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.0%
3/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.8%
3/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.2%
4/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
4/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.4%
3/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
13/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.7%
4/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.2%
2/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
12.2%
6/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
18.4%
9/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.2%
3/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
7/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.2%
2/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.6%
3/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
12/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.5%
14/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.3%
7/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
18.4%
9/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
4/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
40.0%
2/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.7%
25/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.0%
3/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.8%
3/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
18.4%
9/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.2%
5/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
14.6%
7/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.9%
4/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.7%
4/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.2%
2/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.2%
5/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
3/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
17.1%
6/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.7%
23/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
5/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
9.7%
6/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
22.4%
11/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.4%
5/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Migraine
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
6/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.9%
4/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.9%
4/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
7/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.7%
4/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.8%
3/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
40.0%
2/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
12.6%
27/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
5/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.1%
5/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
22.4%
11/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.2%
5/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
18.8%
9/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.3%
5/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.9%
4/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.3%
5/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.4%
3/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.2%
4/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Reproductive system and breast disorders
Testicular oedema
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Vascular disorders
Flushing
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
50.0%
2/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
60.0%
3/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.2%
54/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.7%
7/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
9.7%
6/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
40.8%
20/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
24.5%
12/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
18.8%
9/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.2%
5/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.1%
4/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.7%
9/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
14.5%
9/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.7%
6/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.9%
19/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.7%
7/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.1%
5/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
14.3%
7/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.3%
8/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
18.8%
9/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
6/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.8%
3/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
6/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.5%
4/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.7%
8/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.2%
2/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
3/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
40.0%
2/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
6/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.2%
2/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.9%
4/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.2%
4/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.3%
5/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
2/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.2%
4/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
4/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
15.4%
2/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.4%
3/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.4%
3/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
7/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
22.6%
14/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.4%
5/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.6%
3/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.4%
3/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.2%
2/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
40.0%
2/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.5%
14/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.0%
3/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
12.9%
8/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.2%
4/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.7%
2/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.2%
2/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.47%
1/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.4%
3/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.9%
4/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
13.3%
8/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
46.8%
29/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
36.1%
13/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
40.0%
14/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
46.2%
6/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
40.0%
2/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.2%
71/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
21.7%
13/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.3%
7/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
55.1%
27/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
49.0%
24/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
37.5%
18/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
26.5%
13/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
30.6%
11/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
28.6%
10/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
66.7%
2/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
53.8%
7/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.1%
43/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.7%
10/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
17.7%
11/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
32.7%
16/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
30.6%
15/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
12/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.7%
6/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.7%
9/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.6%
3/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
7/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.1%
5/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
16.3%
8/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.2%
5/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.2%
3/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.6%
3/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.4%
3/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.1%
1/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.9%
4/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.7%
1/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
5.6%
2/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.2%
4/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.1%
3/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.2%
2/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Vascular disorders
Hot flush
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.93%
2/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
1.6%
1/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
20.0%
1/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
11.2%
24/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
13.3%
8/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
24.2%
15/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.2%
4/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.2%
4/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.3%
4/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
4.1%
2/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
12/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
48.6%
17/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
7.7%
1/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
25.0%
1/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
3.3%
7/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.7%
4/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.5%
4/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
10.2%
5/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
8.2%
4/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
6.2%
3/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.0%
1/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.8%
1/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
2.9%
1/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/1 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/13 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
33.3%
1/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/5 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/3 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/4 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/214 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/60 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/62 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/48 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/49 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/36 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
0.00%
0/35 • Participants were assessed for All-Cause Mortality from the date of their randomization (Cohorts 3, 4, and 6) or first dose (Cohorts 1, 2, and 5) until study completion (assessed up to approximately 144 months). SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (Assessed for approximately 04 months up to a max of approximately 106 months).
The number at Risk for All-Cause Mortality represents all randomized participants (Cohorts 3, 4, and 6) or all participants that received at lease 1 dose of study medication (Cohorts 1, 2, and 5). Serious Adverse Events and Other (Not Including Serious) Adverse Events represent all participants that received at least 1 dose of study medication. Additionally, Cohort 2 participants were pre-specified to be reported together.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER